Product Details for NDA 207925
KALYDECO (IVACAFTOR)
5.8MG/PACKET
Marketing Status: Prescription
13.4MG/PACKET
Marketing Status: Prescription
25MG/PACKET
Marketing Status: Prescription
50MG/PACKET
Marketing Status: Prescription
75MG/PACKET
Marketing Status: Prescription
5.8MG/PACKET
Marketing Status: Prescription
Active Ingredient: IVACAFTOR
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 5.8MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207925
Product Number: 004
Approval Date: May 3, 2023
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
KALYDECO (IVACAFTOR)
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 5.8MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207925
Product Number: 004
Approval Date: May 3, 2023
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
13.4MG/PACKET
Marketing Status: Prescription
Active Ingredient: IVACAFTOR
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 13.4MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207925
Product Number: 005
Approval Date: May 3, 2023
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
KALYDECO (IVACAFTOR)
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 13.4MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207925
Product Number: 005
Approval Date: May 3, 2023
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
25MG/PACKET
Marketing Status: Prescription
Active Ingredient: IVACAFTOR
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 25MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207925
Product Number: 003
Approval Date: Apr 29, 2019
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
KALYDECO (IVACAFTOR)
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 25MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207925
Product Number: 003
Approval Date: Apr 29, 2019
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
50MG/PACKET
Marketing Status: Prescription
Active Ingredient: IVACAFTOR
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 50MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207925
Product Number: 001
Approval Date: Mar 17, 2015
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
KALYDECO (IVACAFTOR)
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 50MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N207925
Product Number: 001
Approval Date: Mar 17, 2015
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
75MG/PACKET
Marketing Status: Prescription
Active Ingredient: IVACAFTOR
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 75MG/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N207925
Product Number: 002
Approval Date: Mar 17, 2015
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: KALYDECO
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: 75MG/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N207925
Product Number: 002
Approval Date: Mar 17, 2015
Applicant Holder Full Name: VERTEX PHARMACEUTICALS INC
Marketing Status: Prescription
Patent and Exclusivity Information